Revised: April 2012
AN: 01788/2011
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Cyclo Spray, Chlortetracycline HCl 2.45 % w/w, cutaneous spray, suspension for
pigs, sheep and cattle.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Substance:
Chlortetracycline HCl.
The active ingredient content is 2.45 % w/w
Excipients:
Patent Blue V, colouring agent
Butane 100
0.15 % w/w
68.77 % w/w
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Cutaneous Spray, suspension
Blue colored
4.
CLINICAL PARTICULARS
4.1
Target species
Cattle, sheep and pigs.
4.2
Indications for use, specifying the target species


4.3
Prevention of infections of superficial traumatic or surgical wounds caused by
micro-organisms sensitive to chlortetracycline.
The product can be used as part of a treatment for superficial claw/hoof
infections, in particular interdigital dermatitis (foot rot) in sheep and digital
dermatitis in cattle.
Contraindications
Do not use in case of hypersensitivity to tetracyclines.
4.4
Special warnings for each target species
None
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4.5
Special precautions for use
i.
Special precautions for use in animals
Protect the eyes when spraying in the vicinity of the head. Clean the affected
area thoroughly before spraying. Treatment of foot conditions should always
be preceded by appropriate paring of the hoof, as this is critical for achieving
an adequate response. After spraying the feet, the animal should be kept on
dry ground for at least one hour.
The animal should be discouraged from licking the treated area, or treated
areas on other animals.
ii.
Special precautions to be taken by the person administering the veterinary
medicinal product to animals
Direct contact with the skin should be avoided because of sensitisation,
contact dermatitis and possible hypersensitivity reactions to chlortetracycline.
Wear appropriate impermeable gloves whilst handling the product.
Because of risk of eye irritation, contact with the eyes should be avoided.
Protect the eyes and face.
Do not spray on a naked flame or any incandescent material. Do not pierce
or burn the container, even after use.
Avoid inhaling vapours. Apply the product in open air or in sufficiently
ventilated area.
Wash hands after use.
Do not eat or smoke whilst administering the product.
In case of accidental ingestion or in case of contact with eyes, seek medical
advice immediately and show the label to the physician.
4.6
Adverse reactions (frequency and seriousness)
Hypersensitivity reactions may occur rarely.
4.7
Use during pregnancy, lactation or lay
Following cutaneous administration of CYCLO SPRAY, absorption of
chlortetracycline is negligible and it is not detectable in the milk.
4.8
Interactions with other veterinary medicinal products and other forms of
interaction
After cutaneous administration of chlortetracycline spray, absorption of
chlortetracycline is negligible. No data on interactions with other local treatments
are available.
4.9
Amounts to be administered and administration route
CYCLO Spray is indicated for cutaneous administration. Shake the container
thoroughly before spraying. The container should be held at a distance of 15-20 cm
from the area to be sprayed; spray for approximately 3 seconds (equivalent to
approximately 3.9 g of product or 0.10 g chlortetracycline) until the treatment-area
is evenly coloured. In case of claw/hoof infections this treatment should be
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AN: 01788/2011
repeated after 30 seconds.



For prevention of infections after superficial traumatic or surgical wounds a
single administration is recommended.
For treatment of Dermatitis Digitalis, a double administration (with a 30
second interval) is recommended daily for three consecutive days.
For treatment of other hoof infections (foot rot), a double administration (with
a 30 second interval) is recommended. Dependent on the seriousness of the
injury and the rate of improvement treatment should be repeated within 1 to
3 days
4.10 Overdose (symptoms, emergency procedures, antidotes) if necessary
Not applicable
4.11 Withdrawal periods
Meat
: zero days
Milk
: zero hours
Do not use on the udder of lactating animals if milk is intended for human
consumption.
Stained part of the pigskin must be removed prior to the rest of the animal being
used for human consumption.
5.
PHARMACOLOGICAL PROPERTIES
5.1
Pharmacodynamic properties
Chlortetracycline belongs to the pharmacotherapeutic group of tetracycline
antibiotics.
ATC vet code: QD06AA02
In vitro, chlortetracycline is primarily bacteriostatic. Chlortetracycline exerts its
action by inhibiting the protein synthesis of the bacterial cell. Especially cell-division
and the formation of the cell wall are impaired. Chlortetracycline binds to receptors
on the 30S-subunit of the bacterial ribosome where they interfere with the binding
of the aminoacyl-transfer RNA to the acceptor site on the messenger RNA
ribosome complex.
5.2
Pharmacokinetic particulars
Following cutaneous administration of chlortetracycline spray, chlortetracycline
absorption is negligible. Therefore CYCLO SPRAY will only have a local effect, no
systemic effects are to be anticipated.
6.
PHARMACEUTICAL PARTICULARS
6.1
List of excipients
Patent Blue V [E 131]
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AN: 01788/2011
Butane (Butan 100)
Colloidal anhydrous silica (Aerosil 200)
Isopropyl alcohol
Sorbitan trioleate (Span 85)
6.2
Incompatibilities
None known
6.3
Shelf life
Shelf-life of the veterinary medicinal product as packaged for sale: 3 years
6.4
Special precautions for storage
Pressurized container. Do not expose the container to direct sunlight or to
temperatures higher than 50°. Keep away from sources of ignition.
6.5
Nature and composition of immediate packaging
270 ml or 520 ml pressurised container of coated tin plate with a plastic valve
mechanism and spraying nozzle. Not all pack sizes may be marketed.
6.6
Special precautions for the disposal of unused veterinary medicinal products
or waste materials
Any unused veterinary medicinal product or waste materials derived from such
veterinary medicinal products should be disposed of in accordance with local
requirements.
7.
MARKETING AUTHORISATION HOLDER
Eurovet Animal Health B.V.
Handelsweg 25
PO Box 179
5530 AD Bladel
The Netherlands
8.
MARKETING AUTHORISATION NUMBER
Vm 16849/4002
9.
DATE OF FIRST AUTHORISATION
Date: 14 August 2006
10.
DATE OF REVISION OF THE TEXT
Date: April 2012
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